In addition to application of antimicrobial composition to hands, skin site preparation (surgical, catheter, wound, and patient) is a key component of integrated infection control program in all hospitals. Similarly in non-surgical situations, acne (acne vulgaris affecting the hair follicles and oil-secreting glands of the skin and manifesting as blackheads (comedones), whiteheads (pustules), and inflammation (papules), and acne conglobata- a more severe form, with deep cyst formation and subsequent scarring) is the most common of all skin problems and widely seen in younger population. Also, skin lesions (e.g., pseudofolliculitis barbae ("PFB")) before, during or after shaving are a major problem.
Current skin prep products used in hospitals are prone to some disadvantages such as: 1) irritation; 2) potential for cellular oxidative reactions (Iodine and its derivatives); 3) poor antimicrobial activity against resistant microbes and emerging organisms; 4) lack of aesthetics; 5) Lack of residual activity (iodine based formulations); and 6) lack of colorants for site identification (chlorhexidine gluconate "CHG" formulations). Similarly salicylic acid or benzoyl peroxide-based formulations cause either irritations or oxidative reactions. These reactions could potentially generate materials such as super oxides and other mutagens, and as a result there is a need to develop compositions that are much safer to skin with potential staining and anti-inflammatory properties while exhibiting antimicrobial activity against inflammation, odor or disease causing pathogens.
The significance of proper prepping and usage of antimicrobials is on the rise, as nosocomial infections are becoming a major problem to health care organizations. Iodine and iodine-based products are being used due to their immediate activity against resident flora and also inherent staining properties as a site indicator for prepping or for needle insertion. Advancement in iodine based technology has occurred, and as a result number of new technologies emerged to overcome certain negative features of iodine. However, iodine or iodine-based technologies do not offer any residual activity, as a result the regrowth of resident flora is noted above the baseline over period of time. This feature limits the usage of iodine based products where persistent antimicrobial activity is an essential feature on moist and dry areas. It is well established that iodine based products exhibit activity by oxidizing microbial cellular components, while showing undesired irritations and sensitization's on human skin. At present combination of iodine and alcohol preparations are being developed to compete with CHG market. It is noteworthy that alcohol and iodine combination may increase irritation potential unless the blend is formulated in an emollient or gel based matrix, and yet, the combination may not exhibit residual activity comparable to CHG formulations. Though CHG based formulations are currently marketed as skin preps, the limiting factor again would be potential irritations as these products are being used as leave on or wipe-off and rinse-off products.
The negative aspects of current products clearly demands for more potent yet gentle formulations or combinations that display antimicrobial efficacy, staining properties, anti-inflammatory features to reduce any inflammation around surgical site, needle site or non-surgical sites.
Examples of non-surgical sites/inflammations include acne, pseudofolliculitis, infected areas by fungus, insects, viruses, sun burns, rash, dermatitis, Tinea pedis (Athlete's foot), scleroderma, psoriasis, atopic dermatitis, genital infections, dermatoses and itching, skin cancer, bacterial infections, alopecia and other infections.
Plants and plant products have been used historically as chemopreventative products. In recent years, advancement in technology, miniaturization and high throughput screening has dramatically changed the bioactive compound discovery process. Number of active molecules were identified and with modifications in structures/functionalities several compounds have been commercialized to improve human health. The best recent examples are taxol from Taxus brevifolia, vincristine and vinblastin from Vinca rosea, and several other compounds. In recent years, naturals/botanicals/herbal products gained momentum in cosmetic and dietary product development. Natural products have several advantages over synthetic compounds in their slow and steady action with excellent safety profile. The research and development of novel compounds from natural source (Cosmeceuticals and Neutraceuticals) and evaluation of such compounds for their biological activity has seen all over the world. Most of the plant mixtures are ingested as dietary supplements but some are applied topically to treat various skin conditions. Ayurveda, the ancient Indian Materia Medica believes that such combinations produce a synergism where by the beneficial effects of the whole is greater than the sum of its parts. Among several plants or plant extracts, the following are known to exhibit favorable effects on skin conditions such as anti-irritant, wound healing and skin lesions:
anti-irritant: Amalaki (Indian gooseberry) PA1 wound healing and skin lesions: Gotukola PA1 cancerous lesions-breast, skin, vulva: Curcum longa PA1 antiseptic/astringent: Guggui (a gum resin), PA1 Hydrastis canadensis (Golden seal) PA1 anti-inflammatory: Licorice PA1 skin ulcer, boils: Shallaki PA1 drug delivery system: Mango butter PA1 speeding cellular renewal: high mineral content of many muds PA1 immediate and Persistent antimicrobial activity against skin flora (resident and transient ) PA1 staining properties to locate the surgical site or catheter site. PA1 anti-inflammatory properties (anti-acne, pseudofolliculitis/skin lesions) PA1 reduction in skin prep time PA1 wound cleansers PA1 a) an antimicrobial selected from the group consisting of more than 30% by volume alcohol, an effective amount of triclosan and mixtures thereof; PA1 b) an effective amount of phenoxy ethanol, an effective amount of benzalkonium chloride or benzethonium chloride; and an effective amount of PHOSPOLIPID CDM; and PA1 c) an effective amount of a naturally occurring plant or extract thereof. PA1 1. Ethyl alcohol (40-70%), Isopropyl alcohol (20-25%),n-Propyl alcohol (5-10%). PA1 2. Diisobutyl Phenoxy Ethoxy Ethyl Dimethyl Benzyl Ammonium chloride (0.05-0.5%), commonly known as benzethonium chloride. PA1 3. triclosan, commonly known as, 2, 4, 4'-trichloro-2-hydoxydiphenyl ether (0.2-0.5%) PA1 4. N, N-Bis (Hydroxymethyl) urea (0.08-0.5%), Methyl p-Hydroxybenzoate (0.009-0.5%), Propyl p-Hydroxy benzoate (0.0025-0.5%), 1, 2-Propane diol (0.050-0.056%), PA1 5. Coco Phosphotidyl PG-Dimonium chloride (0.05-0.5%) PA1 6. DL- and L-Ofloxacin (0.01-0.5%) PA1 7. Australian Tea Tree oil (1.0-5.0%) PA1 8. Lemongrass oil (1.0-5.0%) PA1 9. Thyme oil (1.0-5.0%) PA1 10. Lavender oil (1.0-5.0%) PA1 11. Clove oil (1.0-5.0%)
There is overwhelming interest in natural ingredients for cleansing, coloration, and treatment of skin, wounds, scalp and hair. Since ancient times, humans have used preparations derived from plants to dye their hair, and skin and to heal their wounds.
The tropical plant, Curcuma longa is widely consumed in Asia for variety or purposes. Turmeric (Curcuma longa) has been used to combat a variety of ailments such as cancer prevention. Volatile oil from the rhizomes displayed mosquitocidal activity. It is reported in the literature that ethyl acetate (EtOAC) extract yielded Curcumin 1, 2, and 3 which have shown inhibitory activity against topoisomerase -I and -II. Curcumin or turmeric yellow has a MW 368 and is the dyestuff from the root of curcuma longa and it is insoluble in water but soluble in alcohol. The striking feature of the extract is intense coloring characteristic with anti-inflammatory, anti-cancer, and wound healing properties. Similarly, extracts and pure compounds of Hydrastis canadensis (Golden seal), Croccus sativus (Saffron) and Alkanna tinctoria (Henna root) also known as cosmetic dyes due to their astringent properties. Though these features are known in the literature the coloring features of these extracts or pure compounds have not been used to develop preparations to prep surgical, catheter, wound and other non-surgical sites. In particular, these features have not been explored in combination with alcohol based gels such as gels containing naturally derived biomimmetic phospholipids along with preservatives to offer the following benefits:
Accordingly, there is a continuing desire for antimicrobial compositions that are antimicrobially effective while also having therapeutic (anti-inflammatory) benefits and, when desired, staining properties to indicate a disinfected site.